Bioequivalence of Pramipexole Extended Release (PPX ER) 1.5mg x 1 Tablet Once Daily (q.d.) vs. PPX ER 0.375mg x 4 Tablets Under Fasted and Fed Conditions in Japanese Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: PPX ER

• Registration Number: NCT01119443
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

Bioequivalence between PPX ER 1.5 mg x 1 tablet q.d. and 0.375 mg PPX ER x 4 tablets q.d. under fasted and fed conditions Food effect of 1.5 mg ER x 1 tablet q.d.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-05-05
• Study First Submitted QC: 2010-05-06
• Study First Posted: 2010-05-07
• Primary Completion: 2010-06
• Results First Submitted: 2011-05-30
• Results First Submitted QC: 2011-05-30
• Results First Posted: 2011-06-27
• Status Verified: 2014-05
• Last Update Submitted: 2014-06-03
• Last Update Posted: 2014-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 28

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment sequence A	PPX ER	V4: PPX ER 1.5mg x 1 fed, V5: PPX ER 0.375mg x 4 fed, V6:: PPX ER 1.5mg x 1 fasted, V5: PPX ER 0.375mg x 4 fasted
Treatment sequence B	PPX ER	V4: PPX ER 0.375mg x 4 fed, V5: PPX ER 1.5mg x 1 fed, V6:: PPX ER 0.375mg x 4 fasted, V5: PPX ER 1.5mg x 1 fasted

Primary Outcome Measures

Name	Time	Method
AUCτ,ss (Fed Conditions)	Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration	Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ
Cmax,ss (Fed Conditions)	Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration	maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ
AUCτ,ss (Fasted Conditions)	Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration	Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ
Cmax,ss (Fasted Conditions)	Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration	maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ

Secondary Outcome Measures

Name	Time	Method
Cτ,ss (Fed Conditions)	pharmacokinetic blood samples collected at τ (23.833 hours) after drug administration	Concentration of the analyte in plasma at time τ at steady state
Cmin,ss (Fed Conditions)	Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration	Minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ
Tmax,ss (Fed Conditions)	Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration	Time from dosing to the maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ
λz,ss (Fed Conditions)	Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration	Terminal rate constant of the analyte in plasma at steady state
t1/2,ss (Fed Conditions)	Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration	Terminal half-life of the analyte in plasma at steady state
MRTpo,ss (Fed Conditions)	Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration	Mean residence time of the analyte in the body at steady state after oral administration
Cτ,ss (Fasted Conditions)	pharmacokinetic blood samples collected at τ (23.833 hours) after drug administration	Concentration of the analyte in plasma at time τ at steady state
Cmin,ss (Fasted Conditions)	Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration	Minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ
Tmax,ss (Fasted Conditions)	Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration	Time from dosing to the maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ
λz,ss (Fasted Conditions)	Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration	Terminal rate constant of the analyte in plasma at steady state
t1/2,ss (Fasted Conditions)	Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration	Terminal half-life of the analyte in plasma at steady state
MRTpo,ss (Fasted Conditions)	Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration	Mean residence time of the analyte in the body at steady state after oral administration

Trial Locations

Locations (1)

248.677.001 Boehringer Ingelheim Investigational Site; 🇯🇵 Sumida-ku, Tokyo, Japan